| Product NDC: | 59630-993 |
| Proprietary Name: | Magnacet |
| Non Proprietary Name: | oxycodone and acetaminophen |
| Active Ingredient(s): | 400; 7.5 mg/1; mg/1 & nbsp; oxycodone and acetaminophen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59630-993 |
| Labeler Name: | Shionogi Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040698 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20111017 |
| Package NDC: | 59630-993-10 |
| Package Description: | 100 TABLET in 1 BOTTLE, PLASTIC (59630-993-10) |
| NDC Code | 59630-993-10 |
| Proprietary Name | Magnacet |
| Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (59630-993-10) |
| Product NDC | 59630-993 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | oxycodone and acetaminophen |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20111017 |
| Marketing Category Name | ANDA |
| Labeler Name | Shionogi Inc |
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| Strength Number | 400; 7.5 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |